Biguanide

Type 2 Diabetes Mellitus

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>INVOKAMET ®(canagliflozin and metformin HCl) and INVOKAMET ®XR (canagliflozin and metformin HCl extended-release tablets) contain canagliflozin and metformin HCl. <div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>CanagliflozinCanagliflozin is an inhibitor of SGLT2, the transporter responsible for reabsorbing the majority of glucose filtered by the kidney. Canagliflozin is chemically known as (1 S)-1,5-anhydro-1-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-D-glucitol hemihydrate and its molecular formula and weight are C 24H 25FO 5S∙1/2 H 2O and 453.53, respectively. The structural formula for canagliflozin is: <div class="Figure"><img alt="Chemical Structure" src="invokamet-01.jpg"/></div>Canagliflozin is practically insoluble in aqueous media from pH 1.1 to 12.9.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin HCl is a biguanide chemically known as 1,1-Dimethylbiguanide HCl and its molecular formula and weight are C 4H 11N 5∙ HCl and 165.62, respectively. The structural formula for metformin HCl is: <div class="Figure"><img alt="Chemical Structure" src="invokamet-02.jpg"/></div></div><div class="Section" data-sectioncode="42229-5"><a name="section-10.3"></a>INVOKAMET and INVOKAMET XRINVOKAMET or INVOKAMET XR are supplied as film-coated tablets for oral administration. Each 50 mg/500 mg tablet and 50 mg/1,000 mg tablet contains 51 mg of canagliflozin equivalent to 50 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).Each 150 mg/500 mg tablet and 150 mg/1,000 mg tablet contains 153 mg of canagliflozin equivalent to 150 mg canagliflozin (anhydrous) and 500 mg or 1,000 mg metformin HCl (equivalent to metformin 389.93 mg and 779.86 mg, respectively).INVOKAMET contains the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, and microcrystalline cellulose. The magnesium stearate is vegetable-sourced. The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide yellow (50 mg/1,000 mg and 150 mg/500 mg tablets only), iron oxide red (50 mg/1,000 mg, 150 mg/500 mg and 150 mg/1,000 mg tablets only), and iron oxide black (150 mg/1,000 mg tablets only).INVOKAMET XR contains the following inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate (vegetable-sourced), microcrystalline cellulose, polyethylene oxide, and silicified microcrystalline cellulose (50 mg/500 mg and 50 mg/1,000 mg tablets only). The tablets are finished with a commercially available film-coating consisting of the following inactive ingredients: macrogol/PEG3350, polyvinyl alcohol (partially hydrolyzed), talc, titanium dioxide, iron oxide red, iron oxide yellow, and iron oxide black (50 mg/1,000 mg and 150 mg/1,000 mg tablets only).INVOKAMET XR tablets provide canagliflozin for immediate-release and metformin HCl for extended-release. Each bilayer tablet is compressed from two separate granulates, one for each active ingredient of the tablet, and finished with a film-coating. The metformin HCl extended-release layer is based on a polymer matrix which controls the drug release by passive diffusion through the swollen matrix in combination with tablet erosion.</div></section>

INVOKAMET

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 150 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 1000 MG Extended Release Oral Tablet [Invokamet]

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet

24 HR canagliflozin 50 MG / metformin hydrochloride 500 MG Extended Release Oral Tablet [Invokamet]

Invokamet

canagliflozin

canagliflozin / metformin

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 150 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 1000 MG Oral Tablet [Invokamet]

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet

canagliflozin 50 MG / metformin hydrochloride 500 MG Oral Tablet [Invokamet]

metformin

metformin hydrochloride

<section class="Section" data-sectioncode="34089-3"><a name="S11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>SEGLUROMET (ertugliflozin and metformin hydrochloride) tablet for oral use contains ertugliflozin L-pyroglutamic acid, a SGLT2 inhibitor, and metformin HCl, a member of the biguanide class.<div class="Section" data-sectioncode="42229-5"><a name="section-10.1"></a>ErtugliflozinThe chemical name of ertugliflozin L-pyroglutamic acid is (1S,2S,3S,4R,5S)-5-(4-chloro-3-(4-ethoxybenzyl)phenyl)-1-(hydroxymethyl)-6,8-dioxabicyclo[3.2.1]octane-2,3,4-triol, compound with (2S)-5-oxopyrrolidine-2-carboxylic acid. The molecular formula is C27H32ClNO10 and the molecular weight is 566.00.The chemical structure is:<img alt="Chemical Structure" src="segluromet-01.jpg"/>Ertugliflozin L-pyroglutamic acid is a white to off-white powder that is soluble in ethyl alcohol and acetone, slightly soluble in ethyl acetate and acetonitrile and very slightly soluble in water.</div><div class="Section" data-sectioncode="42229-5"><a name="section-10.2"></a>Metformin HClMetformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents. The structural formula is as shown:<img alt="Chemical Structure" src="segluromet-02.jpg"/>Metformin HCl is a white to off-white crystalline compound with a molecular formula of C4H11N5∙HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.SEGLUROMET is available as film-coated tablets containing:<ul class="Disc"><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 2.5/500)</li><li>3.24 mg ertugliflozin L-pyroglutamic acid equivalent to 2.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 2.5/1000)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 500 mg metformin HCl (SEGLUROMET 7.5/500)</li><li>9.71 mg ertugliflozin L-pyroglutamic acid equivalent to 7.5 mg of ertugliflozin and 1,000 mg metformin HCl (SEGLUROMET 7.5/1000)</li></ul>Inactive ingredients are povidone, microcrystalline cellulose, crospovidone, sodium lauryl sulfate, and magnesium stearate.The film coating contains: hypromellose, hydroxypropyl cellulose, titanium dioxide, iron oxide red, and carnauba wax.</div></section>

SEGLUROMET

Segluromet

ertugliflozin

ertugliflozin / metformin

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 2.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 1000 MG Oral Tablet [Segluromet]

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet

ertugliflozin 7.5 MG / metformin hydrochloride 500 MG Oral Tablet [Segluromet]

Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus.

Additionally, Invokamet XR serves as a preventive measure to reduce the risk of fatality due to heart attack, stroke, or heart failure in adults who have type 2 diabetes and coexisting heart disease. It is also employed to diminish the likelihood of end-stage kidney disease and hospitalization or fatality stemming from heart issues in individuals with kidney problems linked to type 2 diabetes.

It's important to note that Invokamet XR is not intended for the treatment of type 1 diabetes.

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Instructions For Use: Diabetes

Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while metformin reduces the amount of sugar released by the liver into the blood.

This medication is prescribed alongside diet and exercise to enhance blood sugar management in adults diagnosed with type 2 diabetes mellitus. It's important to note that Segluromet is not intended for the treatment of type 1 diabetes.

Invokamet XR ®(metformin hydrochloride)	Segluromet®(metformin hydrochloride)

Prescription Only Invokamet XR is a medication that, when combined with dietary and exercise measures, is prescribed to enhance blood sugar management in adults diagnosed with type 2 diabetes...	Prescription Only Segluromet is a medication that combines ertugliflozin and metformin to regulate blood sugar levels. Ertugliflozin aids the kidneys in removing glucose from the bloodstream, while...
Dosage & Administration
Administration
Oral . Learn more.	Oral . Learn more.
Dosing
INVOKAMET XR: two tablets, once daily with the morning meal. Swallow whole. Never crush, cut, or chew. . Learn more.	Maximum recommended dose is 7.5 mg ertugliflozin/1,000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation. Do not use in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/minute/1.73 m2 . . Learn more.
Latin Shorthand
2 tabs, 1x daily with AM meal. Swallow whole, do not crush, cut, or chew.. Learn more.	Max dose: 7.5 mg ertugliflozin / 1000 mg metformin BID. Take with meals, gradual dose increase. Avoid if eGFR < 30 mL/min/1.73 m².. Learn more.
Financial Assistance
Out-Of-Pocket Costs With Copay Card
$0. Learn more.	$0. Learn more.
Annual Cap
$3000 and $200 per month. Learn more.	$583 per fill . Learn more.
Assistance Expiration
Calendar year. Learn more.	12 uses. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Physician Advisory
Adverse Reactions
Most common adverse reactions associated with canagliflozin (5% or greater incidence): female genital mycotic infections, urinary tract infection, and increased urination. Most common adverse reactions associated with metformin HCl (5% or greater incidence) are diarrhea, nausea, vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache.. Learn more.	Most common adverse reactions associated with ertugliflozin (incidence ≥5%) were female genital mycotic infections. Most common adverse reactions associated with metformin (incidence ≥5%) were diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. . Learn more.
Mechanism of Actions (MoA)
SGLT2 Inhibitors. Learn more.	SGLT2 Inhibitors. Learn more.
Special Populations

Invokamet XR ® Alternatives